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  5. Label Information: Sunmark Junior Rapid Melts

FDA Label for Sunmark Junior Rapid Melts

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
    8. STOP USE AND ASK A DOCTOR IF
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PDP

Sunmark Junior Rapid Melts Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Acetaminophen 160 mg


Purpose



Pain reliever/ fever reducer


Uses



temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • temporarily reduces fever

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen.

Do Not Use



  • with any other product containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use If Your Child Has



liver disease


Ask A Doctor Or Pharmacist Before Use If Your Child Is



taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition

    Keep out of reach of children.

    Overdose warning: Thaking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.


Directions



  • this product does not contain directions or complete warnings for adult dose
  • do not give more than directed (see overdose warning)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • dissolve in mouth, or chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.
    •  Weight (lb) Age (yr) Tablets
     under 48 lbs under 6 years ask a doctor
     48-59 lbs 6-8 years 2
     60-71 lbs 9-10 years 2 1/2
     72-95 lbs 11 years 3


Other Information



  • store at controlled room temperature betweeen 20-25oC(68-77oF)
  • see end flap for expiration date and lot number

Inactive Ingredients



acesulfame pottasium, citric acid, D&C red 27 aluminum lake, dextrose, FD&C blue 1 aluminum lake, flavors, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose powder, polyplasdone, sorbitol, sucralose.

May contain ethylcellulose, gelatin, sodium polyphosphate, silicon dioxide.


Pdp



Sunmark

Junior Rapid Melts

Compare to JR. Tylenol Meltaways active ingredient

Pain reliever

Fever reducer

Acetaminophen

Pain reliever/Fever Reducer

For ages 6-11 years

Bubblegum Flavor

24 Tablets

Box - SM220

Box - SM220


* Please review the disclaimer below.